Germany-based sterna biological has revealed positive results from the SECURE study, a Phase 2a trial in patients with moderate to severe ulcerative colitis treated with the company's GATA-3 specific DNAzyme formulation, SB012, it was reported yesterday.
The study is a prospective, multi-centre, randomised and double-blind placebo-controlled trial designed to evaluate patients with moderate to severe ulcerative colitis. The firm has randomised 20 patients to receive topically applied SB012 enema or placebo once daily for 28 days.
According to the company, the primary efficacy variable was the change in disease activity after 28 days of treatment. The company has assessed the endpoints of the trial at day 56. According to the company, there was a statistically significant improvement in the Mayo Score in the SB012 at day 28 compared with the placebo group.
The product is an enema formulation of hgd40, which is a new DNAzyme that specifically binds and inactivates GATA-3 mRNA and subsequent GATA-3 protein expression.
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